Originally Posted by harinandu2003
Harry,
Design and Development verification and validation records are being kept, but not the Production inspection reports. I would have agreed with you if were responsible for design only and were just like a design service provider, but we are an Original Equipment Manufacturer for the complete product ranging from Hardware , Embedded Software, Application Software etc, we are integrating these diverse designs to finally deliver the solution. I understand that production just being one among them cannot be excluded from our scope and we are ultimately responsible for product quality, we will answerable to quality for any issues.
So there is no question that Production is not under our scope and it has to be in our scope. But should we keep the entire inspection reports for the units being manufactured for us, in our office location and whether keeping those at the outsourced facility would suffice is my question?, I can bring some samples of the test reports but bringing thousands of them and keeping it here doesn;t seem to be practical.
We have defined in our Product Quality Plan the processes/ test stages which have to be done by the Subcontractor.But the thing I am not sure about is whether the compliance records should be kept at our facility or not?
So, now its clear that you ARE an OEM, having subcontracted/outsourced your production to the Chinese company, with YOUR specifications, YOUR product quality plan. Hence, this makes you completely responsible for the quality of the product. And this definitely makes you responsible for the production process at the Chiness facility.
Now, coming to your original query! While you do agree to take complete responsibility of your manufactured product (which you should!), including the production part of it, and would like to maintain inspection records to provide evidence of conformity to requirements, this however has nothing to do with an auditor auditing your organization, strictly from the Audit point of view.
Why?
Because, the auditor will only audit the SCOPE. And currently your scope is 'Design of Wireless Products', for which you are maintaining all relevant records in line with the standards requirements including Clause 8.2.4. The auditor has NO RIGHT to go any further trying to audit your production process. No question of that!
Agreed that you
should include production within your scope (and I believe the auditor may suggest you this) in order to gain adequate control over your processes, and ensure sustained product/service quality. I also agree that there should be some methodology to maintain inspection reports of the products being manufactured (not neccesarily bringing down all the hard copies of the reports!). As in the rare event that your product, which is already in the market, has a defect, the root cause can be traced down to the inspection reports for the product.
But, currently based on your scope, you do not have to worry about the audit as Ted, Harry, jkuil and I have mentioned, unless ofcourse there are other issues related to the QMS.
I hope this has helped you and your organization rethink your responsibilities towards your product, and take appropriate measures accordingly.
Ciao.
Note: I realized from Harish's first post that they are going for ISO 9001 certification.